FDA finally put black box warning on all benzodiazepines

[[Buddie]]

Benzos aren't dopaminergic drugs.

FYI Stanford Psychiatrist Anna Lembke shares her opinion about dopamine and benzodiazepines in the video clip below.

Benzodiazepine Withdrawal Difficulties: Stanford Psychiatrist Anna Lembke, M.D.
Medicating Normal
https://youtu.be/-W9EEI2ZXKU

[[Buddie]]

FYI Stanford Psychiatrist Anna Lembke shares her opinion about dopamine and benzodiazepines in the video clip below.

Yeah, I know that video. Brainfart on her part. She casually blurted it out as if benzos are amphetamines. There's limited anecdotal evidence benzos cause dopamine rush and euphoria for some people (that's why benzos are stimulating for those people), but for vast majority they don't. That's why most people aren't dependent on 300+ mg of diazepam or equivalent, and why most people don't feel any sort of craving for benzos. Dopaminergic drugs and activities cause intense cravings however, stuff like porn, gambling, sugar, meth... and that is what fits the addiction criteria.

[[Buddie]]

That's a good point, it's like the primidone that I take, it metabolizes into phenobarbital. Phenobarbital is controlled, and primidone is not.

So whenever I take a urine test, I test positive for barbiturates. But the thing is, primidone does not make you feel like phenobarbital. And once this withdrawal process is over, I'm going to quit taking it.

So basically, legal or not, and prescribed or not, doesn't make a difference. Neither does addiction, makes no difference with benzos. Either you're screwed or you're not. And either you've got withdrawal or you don't.

[[Buddie]]

https://www.benzoinfo.com/2016/09/05/dont-harm-them-twice-when-the-language-surrounding-benzodiazepines-adds-insult-to-injury-part-1/

...When it matters.. -It can really matter...

[[Buddie]]

My doctor says that I'm a drug addict, and that I'm recovering from addiction because I'm still going through benzo withdrawal. Prior to stopping the benzos, she only said I had a neurological condition that required medicine. So yes, the words they use can be really negative. Aside from that, it doesn't change anything.

At least in my mind, it's all the same. Because it's like right now, whether I'm a drug addict or not, I'm going to be bed bound with agoraphobia trying to heal for the next couple years. My finances will be the same regardless of my label. And the medical attention and doctors I go to will be the same regardless.

And for the people that don't think they were ever addicted, why did they [...] several failed attempts at quiting? If they were not addicted, they should [...] just stayed off of them. But we all know, it's a severe addiction. You can get addicted within the first couple days.

Or think of it like this, let's say it was a street drug instead of a prescription drug. If somebody took them a couple times and felt good, and then decided they would take them for another week or two, and then all of a sudden can't get off, what else would you call it? I'm pretty sure that would be called addiction. A prescription doesn't make it any different other than legal or not. It doesn't [...] to give you Euphoria to feel good.

At the same time, I [...] wondered myself is it just physical dependence and not addiction at all? I guess that's completely possible too. Like for example, maybe they use the word Addiction on everything that you do repetitively for no reason. Maybe they shouldn't use the word Addiction with things like food and benzos and gambling, because it doesn't get you high. So maybe the word and term addiction is overused.

But that's getting technical. At the end of the day, the only thing that matters is did you get off of the benzos and stay off of them like you want? And are you getting yourself better and[...] with your life? If so, and you're healthy, it really doesn't matter what the label is. And I don't think there's anything wrong with being a drug addict other than the suffering and financial issues and legal problems that come along with it. And sometimes some bad things happen.

Maybe if Society didn't make out drug addicts to be bad people, people wouldn't be having this debate on benzo buddies nonstop. Everybody has the immediate denial of being one and gets all worked up for no reason. It doesn't even matter, just get yourself better.

[[Buddie]]

My point has nothing to do with good or bad, labels, or whateva.. Its about the right treatment protocols and correct support for each situation..

Like not being escalated up in dose because Drs clearly see one ISNT an addict/ed, but dont understand the severity of tolerance and physical dependence.. (oh it must be increasing pain, or anxiety, or insomnia, or whateva.. -Take more..). Furthermore, through denial of WD SX (the dependence) I [...] seen it lead to unnecessary surgical procedures and worse..

Then later or alternately, -“Its addiction”, -thus detox, CT, and “rehab” will solve the problem..
That just left me protracted, polydrugged, and counting new losses daily..

Im not here to dictate anyones situation, but no one can tell me language and its understanding [...] impact treatment protocols, and that treatment protocols dont correlate with the “experience” or outcome...

 Perhaps if one is maintaining a CT then it’s a moot point by then, the (potential) damage is already done, assuming we are talking about a tolerance or physical dependence situation..  Were is solely an addiction situation, then great, one as well on their way to healing or perhaps a sobriety..

But what if its both.. -Thats where it gets tricky I guess.. One would [...] to decide what takes precedent, if things like dose management [...] be maintained through a taper..

If one doesnt believe tapers of varying and personal length are “best practice”, then thats another story... -Hopefully one without a strong physical dependence involved..

At a personal level, -whatever works and gets one through is fine by me.. My concern is the bigger, broader picture where language affects treatment...
-as explained in the above link..

[[Buddie]]

And for the people that don't think they were ever addicted, why did they [...] several failed attempts at quiting? If they were not addicted, they should [...] just stayed off of them. But we all know, it's a severe addiction. You can get addicted within the first couple days.

The difference between addiction and dependence can be shown by an example. Say you're addicted to porn. If you don't get your porn what'll happen to you? Nothing. If you're dependent on benzos and don't get your benzo you'll suffer horrific withdrawal symptoms, and might even get a seizure and die. Of course, there are drugs that cause both addiction and physical dependence, like Adderall, bupropion, opiates, etc. but benzos themselves are more like beta-blockers, or even antihistamines in that they create physical dependence, not cravings.

[[Buddie]]

Here's the website for the MedWatch reporting site.  You can submit a report online about your problems with benzo's.  I just did mine online:

https://www.accessdata.fda.gov/scripts/medwatch/index.cfm

[[Buddie]]

Dear All - havne't been on this site in a long time but wanted to share the below - since i work in the pharmaceutical industry and manage FDA interactions - i receive these alerts - to receive a black box warning is a very significant consequence - sadly - not sure it will deter doctors from continuing to give these meds out like candy - but it means our voices are starting to be heard.

U.S. Food and Drug Administration <usfda@public.govdelivery.com>
Wed 9/23/2020 4:01 PM



Boxed Warning Updated to Improve Safe Use
 MedWatch Header Pharmacy
MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

RECOMMENDATION:

Health Care Professionals

Consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction.
Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.
Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.
Take precautions when benzodiazepines are used in combination with opioid addiction medications.
Patients, Parents, and Caregivers

Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.
Take benzodiazepines and all medicines exactly as prescribed by your health care professional
Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.
Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.
Go to an emergency room or call 911 if you [...] trouble breathing or other serious side effects such as seizures.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Wow!

[[Buddie]]

Freedom of Information Act Results about this.. It seems like our MedWatch reporting drive we all did together played a role in this.

https://www.benzoinfo.com/2020/11/26/fda-foia/